FDA expedites Aspen's prostate drug ahead of merger

The newly merged company will provide women's health, men's health and OTC products. 

By Nicole Gray • Aug. 18, 2016

GSK enters pay-for-performance deal for gene therapy

If Strimvelis does not work in treated children, GlaxoSmithKline must refund the Italian government. 

By Nicole Gray • Aug. 17, 2016

Explore the Trendline➔

Commercialization

New drugs for obesity are becoming blockbusters, while Trump administration pressure is reshaping pharma marketing strategies ahead of looming patent cliffs.

By BioPharma Dive staff

Ipsen hopes to be David to Allergan's Goliath

The French biotech is hoping a new indication for its boulinum toxin Dysport will allow it to compete more effectively with Allergan's market-leading Botox. 

By Nicole Gray • Aug. 17, 2016

ALS Ice Bucket Challenge funds new study

Cytokinetics is fully enrolled in a Phase 3 study that the ALS Foundation helped bankroll. 

By Lisa LaMotta • Aug. 17, 2016

JAMA: PCSK9s should cost $4536, but don't

Roughly nine million Americans with hypercholesterolemia are eligible for PCSK9 inhibitors based on labeling, but JAMA estimates the drugs could cost the health system $120 billion. 

By Nicole Gray • Aug. 17, 2016

Boehringer seeks real-world data to support reversal agent

The pharmaceutical company is hoping to bolster sales of Pradaxa with real-wrold data supporting the use of its anti-coagulant reversal agent Praxabind. 

By Nicole Gray • Aug. 16, 2016

Drug pricing studies anger industry, ICER pushes back

The Institute for Clinical and Economic Review has singled out a number of drugs for being overpriced in recent cost-effectiveness reports. 

By Ned Pagliarulo • Aug. 12, 2016

MannKind maps out Afrezza strategy

After Sanofi broke off its partnership, Mannkind has scaled up to meet the demands of marketing Afrezza by itself. But a turnaround is going to take more than just resources. 

By Lisa LaMotta • Aug. 10, 2016

Why certain drugs don't make the formulary

Express Scripts and CVS Health revealed their new formulary exclusion lists, but why certain drugs don't make the cut isn't always obvious. 

By Lisa LaMotta • Aug. 10, 2016

BIO president defends Orphan Drug Act after op-ed criticism

Jim Greenwood, president and CEO of BIO, contends that the Orphan Drug Act has been a success, despite recent attacks saying it facilitates high drug pricing. 

By Nicole Gray • Aug. 9, 2016

Does MannKind have a shot at a successful Afrezza re-launch?

Matthew Pfeffer, Mannkind's chief financial officer, is trying convince investors that it will. 

By Nicole Gray • Aug. 9, 2016

Allergan's Vraylar launch a success, despite trial failure

Allergan is making headway with its branded pharma business after divesting its generics and distribution businesses.  

By Lisa LaMotta • Aug. 8, 2016

Novo Nordisk sees pricing challenges 'intensifying'

The Danish drugmaker hopes Tresiba can fuel growth moving forward, particularly as pharmacy benefit managers such as Express Scripts tighten the screws on diabetes drug pricing. 

By Ned Pagliarulo • Aug. 8, 2016

Teva's Copaxone still growing despite patent risks

Teva's strategy of transitioning its MS patients to a long-acting version of the drug after a generic challenge appears to have paid off: Copaxone accounted for 49% of the company's profit growth last quarter. 

By Edwin Lopez • Aug. 5, 2016

Gilead: 'We stand behind the pricing of our therapies'

Pushing back on a critical article in The BMJ, Gilead defended its decision to set the list price of Sovaldi at $84,000 per treatment course. 

By Ned Pagliarulo • Aug. 4, 2016

With new exclusions, payers draw line on pricing

CVS Health's decision to list Novartis' biosimilar version of Neupogen also highlighted the growing competitive threat to pricey biologics. 

By Nicole Gray • Aug. 3, 2016

Higher Humira sales lift AbbVie in Q2

Yet with biosimilar competition to Humira threatening, AbbVie has invested heavily in oncology to offset potential revenue loss in the future. 

By Ned Pagliarulo • July 29, 2016

Merck's Keytruda continues gains, driving Q2 revenues higher

But sales of Keytruda remain well behind that of Bristol-Myers' competing immunotherapy Opdivo. Merck hopes to make up ground through new indications in lung cancer. 

By Ned Pagliarulo • July 29, 2016

Bristol-Myers revenues climb on strong Opdivo performance

But sales of the company's other cancer immunotherapy Yervoy declined again, likely impacted by competition. 

By Ned Pagliarulo • July 28, 2016

Amgen boosts sales forecast as Q2 profits jump

Higher sales of Enbrel, Amgen's top-selling drug, helped drive the earnings. 

By Ned Pagliarulo • July 27, 2016

Health plans slow to adopt new drug value assessments: survey

Although rising prices have put a spotlight on prescription drug value, none of the health plans surveyed by Avalere Health indicated they used newly developed value frameworks. 

By Ned Pagliarulo • July 26, 2016

Lilly blames stiff competition for lower US sales of lung cancer drugs

While Lilly had a strong second quarter overall, rival immuno-oncology drugs cut into US sales of Alimta and Cyramza. 

By Ned Pagliarulo • July 26, 2016

Gilead trims guidance as Hepatitis C drug sales slip

Heavily dependent on sales of Harvoni and Sovaldi, Gilead's revenues dropped by nearly 6% in the second quarter, compared to a year prior. 

By Ned Pagliarulo • July 25, 2016

Japanese government to set new controls on specialty drugs: report

Amgen's Repatha and Bristol-Myers' Opdivo will be the first drugs targeted by new guidelines, according to the Nikkei Asian Review. 

By Nicole Gray • July 25, 2016

Ireland, pharma companies agree to deal limiting drug price growth

The deal could limit generic and biosimilar competition by setting pre-defined price reductions upon entry of a copycat drug, critics say. 

By Edwin Lopez • July 22, 2016